At a time of growing interest in antibiotic development, a Wall Street bet on what some billed as a potential blockbuster appears to be going sour.
After regulators on Wednesday released a gloomy assessment of an experimental antibiotic developed by Cempra to combat community-acquired pneumonia, its stock sank as much as 58 percent. That’s because of a safety signal that was seen in another antibiotic called Ketek, which was linked to fatal liver problems years ago and later engulfed the US Food and Drug Administration in scandal.
In documents disclosed in advance of an expert panel meeting that will be held on Friday, FDA staff wrote that they found “a significant safety signal” for liver disease in Cempra’s solithromycin. Although Cempra designed its antibiotic to avoid the sort of side effects that were seen in patients treated with Ketek, agency medical reviewers noted that solithromycin is “structurally, highly related.”
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